510(k) K131260 ยท MSD Catheter, Hemodialysis, Implanted
NMI DIALYSIS CATHETER
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Unknown, Feb 14, 2014 |
| Received | May 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131260
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2026 | Merit Medical Systems, Inc. BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061 Open, Classified |
MSD | None listed |
| May 3, 2024 | Angiodynamics, Inc. BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
Product Number: H965103038181 Open, Classified |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.